MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-11 for TUBING/WING TIP manufactured by Pari Respiratory Equipment, Inc..
[130318186]
Spontaneous call from patient, spoke with patient regarding tubing leak. Patient noticed leak last night but it is very minor; leak is near where tubing and iv line connect. Couriered shipment. Patient had 53 ml left in cassette. No side effects reported. Dose or amount: 30 ng/kg/min; frequency: continuous; route: iv. Dates of use: from (b)(6) 2018 to current; diagnosis or reason for use: pah. Strength: 1. 5mg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082049 |
| MDR Report Key | 8155103 |
| Date Received | 2018-12-11 |
| Date of Report | 2018-11-27 |
| Date of Event | 2018-11-26 |
| Date Added to Maude | 2018-12-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TUBING/WING TIP |
| Generic Name | TUBING, PRESSURE AND ACCESSORIES |
| Product Code | BYX |
| Date Received | 2018-12-11 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PARI RESPIRATORY EQUIPMENT, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-11 |